Идентификация

PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses,
with new restrictions

 EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing the antihistamine hydroxyzine. This follows concerns over the risk of possible effects on heart rhythm with these medicines, which are available in most EU countries. Their approved uses (indications) vary considerably between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and for treatment of sleep disorders.

More information on this, is included in the hyperlink below.

PRAC recommendations to be considered by CHMP for final opinion

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of Corlentor/Procoralan (ivabradine) and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine. Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.

The PRAC made recommendations about the resting heart rate of patients before starting treatment or when the dose is adjusted, recommendations on when treatment should be stopped and recommendations regarding use with other medicines. Because patients treated with Corlentor/Procoralan are at an increased risk of developing atrial fibrillation (a heart condition that causes an irregular and often abnormally fast heart rate), the PRAC recommended monitoring for this condition in patients treated with Corlentor/Procoralan. In addition, the PRAC recommended that, when used for angina, Corlentor/Procoralan should only be used to alleviate symptoms as the available data do not indicate that the medicine provides benefits on outcomes such as reducing heart attack or cardiovascular death (death due to heart problems).

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The PRAC has recommended strengthening the restrictions on the use of valproate medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated. Women for whom valproate is the only option after trying other treatments, should use effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.

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The PRAC has completed an EU-wide review of testosterone-containing medicines following concerns over serious side effects on the heart and blood vessels, including heart attack. The PRAC review did not find consistent evidence that the use of testosterone in men who do not produce enough testosterone (a condition known as hypogonadism) increases the risk of heart problems. The committee considered that the benefits of testosteronecontinue to outweigh its risks but recommended that testosterone-containing medicines should only be used where lack of testosterone has been confirmed by signs and symptoms as well as laboratory tests.

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Review to evaluate cardiovascular risk with high doses taken over long periods

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels).

The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken at lower doses and for short periods of time.

There is therefore no suggestion of a similar cardiovascular risk with ibuprofen as used by the overwhelming majority of patients. Ibuprofen is one of the most widely used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses.

More information is provided in the following hyperlink:

European Medicines Agency starts review of ibuprofen medicines

The Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review at its April meeting.

PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system

The PRAC has advised that the combined use of medicines of different classes acting on the renin-angiotensin (RAS) system, a hormone system that controls blood pressure and the volume of fluids in the body, should not be recommended. The affected medicines (called RAS-acting agents) are used particularly in the treatment of hypertension (high blood pressure) and congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body).

The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) which will adopt the Agency’s final opinion.

More information is provided in the following hyperlink:

Renin-angiotensin-system (RAS)-acting agents

PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small. Update of product information is recommended

European Medicines Agency concludes class review of bisphosphonates and atypical fractures

Benefit-risk review of Multaq started

Important safety information regarding Gadolinium - containing contrast agents and risk of Nephrogenic Systemic Fibrosis (only available in Bulgarian)

European Medicines Agency recommends use of fibrates as second-line treatment